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Fish Oil for HIV-Related Inflamm-aging and Immune Senescence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102724
Recruitment Status : Completed
First Posted : April 3, 2014
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
HIV infection is associated with premature aging of the immune system. It is believe that the persistent inflammation that accompanies HIV infection is a major contributor to premature immune aging. Fish oil has well-documented anti-inflammatory properties. In this randomized, clinical trial, we're testing whether a 12-week course of fish oil supplementation will reverse premature aging in HIV-infected older adults.

Condition or disease Intervention/treatment Phase
HIV Infection Dietary Supplement: Fish oil that contains omega-3 fatty acids Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants were randomized to one of two arms:

Intervention arm = fish oil Control arm = placebo.

Masking: Double (Participant, Investigator)
Masking Description: All gelcaps were overencapsulated to mask their contents
Primary Purpose: Treatment
Official Title: Fish Oil for HIV-Related Inflamm-aging and Immune Senescence
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Fish Oil
Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks.
Dietary Supplement: Fish oil that contains omega-3 fatty acids
Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Other Name: Carlson Brand fish oil

Placebo Comparator: Placebo
Participants will receive 1 gram of oleic sunflower oil for 12 weeks.
Dietary Supplement: Placebo
Gelcaps that contain 1 gram of oleic sunflower oil




Primary Outcome Measures :
  1. Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation [ Time Frame: End of 12-Week Supplementation Period ]
    Markers of immune senescence will include change in the expression of the senescence markers CD28 and CD57 on the surface of peripheral CD4+ and CD8+ T lymphocytes. We will measure the percentage of CD4+ and CD8+ T lymphocytes that are CD28-/CD57- or CD28-/CD57+. We will subtract the percentage obtained at Week 12 from the baseline percentage to calculate the change scores.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented HIV infection
  • between 40 and 70 years of age
  • clinically stable HIV disease as evidenced by a CD4+ T lymphocyte count of > 250 cells/mm3
  • platelet count between 150,000 and 400,000 cells/mm3 to reduce bleeding risks associated with omega 3-fatty acids
  • treatment with a stable HAART regimen for at least six months prior to study entry
  • plasma HIV RNA < 75 copies/ml for at least 12 months
  • elevated plasma concentration of hsCRP (> 2.0 mg/L).

Exclusion Criteria:

  • use within the past month of drugs (e.g., statins, steroids, hormones) and supplements (e.g., omega-3 fatty acids, glucosamine/chondroitin) that have anti-inflammatory effects (excluding non-regular use of aspirin or NSAIDS), or medications or supplements that affect bleeding (e.g., heparin, warfarin, clopidogrel, garlic, ginseng)
  • allergy to fish or shellfish
  • chronic inflammatory condition (e.g., asthma, rheumatoid arthritis), opportunistic infection or cancer, renal impairment (serum creatinine > 2.0 mg/dL), thrombocytopenia (platelet count < 150,000/mm3), bleeding episodes (e.g., gum bleeding, nosebleeds), or a metabolic condition (e.g., diabetes mellitus, thyroid disease)
  • body mass index of > 35, since obesity is associated with inflammation
  • impaired liver function as evidenced by liver enzyme elevations > three times the upper limit of normal (AST or ALT > 150 IU/L)
  • history of prostate cancer
  • LDL cholesterol level > 120 mg/dL
  • lifestyle exclusion factors include use of illicit drugs and consumption of > 3 alcoholic drinks/day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102724


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Barbara A. Swanson, PhD, RN Rush University College of Nursing
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02102724    
Other Study ID Numbers: 5P20MD006886 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2014    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rush University Medical Center:
African Americans
Older Adults
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases